FDA.reportPublic FDA data

De Novo DEN230025

Device
MIRA Surgical System
Contact
florence beck
De Novo number
DEN230025
Product code
SAB
Regulation
878.4962
Classification name
table mounted miniaturized electromechanical surgical system
Decision
granted (DENG)
Decision date
2024-02-23
Date received
2023-04-11
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Direct

Current FDA Classification#

Product code
SAB
Device name
Table Mounted Miniaturized Electromechanical Surgical System
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4962
Implant
N
Life sustain/support
N